CYTX Cytori Therapeutics Inc

Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that it officially filed a formal new drug application pre-submission request to the European Medicine Agency (EMA) for Doxorubicin Hydrochloride Cytori. This submission is the precursor to filing an Article 58 Application for a Marketing Authorization Application (MAA) via EMA’s centralized approval procedure. In June 2017, the EMA Committee for Medicinal Products for Human Use (CHMP) confirmed that Doxorubicin Hydrochloride Cytori was eligible for submission of a MAA via the centralized procedure.  

In addition, in late 2018, the EMA CHMP Name Review Group validated Doxorubicin Hydrochloride Cytori as the official invented name to replace ATI-0918.  Doxorubicin Hydrochloride Cytori is a liposomal nanoparticle medicinal product being developed for cancer patients that contains the active substance doxorubicin, a widely used chemotherapy drug.  Doxorubicin Hydrochloride Cytori is intended for the treatment of breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma.

“Liposomal doxorubicin is a commonly prescribed chemotherapeutic drug for patients with advanced breast and ovarian cancer as well as other indications,” said Dr. Marc Hedrick MD, President/CEO of Cytori Therapeutics.  “Bringing Doxorubicin Hydrochloride Cytori to market in Europe as an alternative to the branded drug is an important near-term corporate goal.”

As a ‘hybrid medicine’, Doxorubicin Hydrochloride Cytori is intended to be similar to a ‘reference medicine’, Adriamycin, already authorized in the EU.  Doxorubicin Hydrochloride Cytori is different than Adriamycin in that the active substance is encapsulated in tiny lipid nanospheres called liposomes that are coated in polyethylene glycol or PEG.  Cytori believes that it has successfully completed all clinical development work for Doxorubicin Hydrochloride Cytori and is currently manufacturing the drug in its dedicated plant in San Antonio, Texas.

Cytori expects to receive assignment of a rapporteur and co-rapporteur, who will work with the company through the MAA submission and review process, by the end of April 2019.  The MAA submission is planned for later in 2019 or early 2020.

Cytori’s MAA will present data from the scientific literature and from non-clinical studies, including comparisons with Janssen’s Caelyx®, an authorized medicine containing doxorubicin in pegylated liposomal form.  The company will also present the results of a completed clinical study intended to investigate whether Doxorubicin Hydrochloride Cytori is ‘bioequivalent’ to Caelyx®, meaning that they both produce the same levels of the active substance in the body.

Janssen’s Caelyx® first received a marketing authorization for the EU in 1996, is currently approved for the treatment of breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma, and generated over €110M in sales across Europe in 2017.  No generic versions of Caelyx® are currently approved and available in Europe.

About Cytori Therapeutics, Inc.

Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. Cytori Nanomedicine™ is developing liposome encapsulated therapies for regenerative medicine and oncologic indications. For more information, visit www.cytori.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, conduct of clinical trials involving our technology, clinical performance, and product approvals, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the conduct of clinical trials, risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

Investor Contact:

Tiago GiraoCytori Therapeutics, Inc.  1-858-458-0900 ir@cytori.com